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Alzheimer DiseaseNCT05477862

Neural Mechanisms of Clinically Designed Improvisatory Music for Alzheimer's Disease

A study testing Clinically Designed Improvisatory Music in people with Alzheimer Disease, run by Northwestern University at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

Clinically Designed Improvisatory Music (CDIM) is a form of improvised music based on calm-inducing sound parameters which brought relief to our cohort of neurology patients. As a direct sound-based approach, CDIM does not rely on autobiographical memory and may have wider applicability and generalizability. Read more about this study

Who is it for?
Ages 55 to 100 yearsHealthy volunteers can take part
Conditions the study is for
Alzheimer Disease
What is being tested?
Clinically Designed Improvisatory Music
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUnited States
Study dates
1 Sep 2023to 15 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 55 to 100 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Cognitively healthy individuals
  • Cognitively healthy control participants evaluated through the Northwestern Mesulam Center. BAI > 8.

Who cannot join

  • Individuals with mild to moderate Alzheimer's disease
  • This group will similarly be recruited through the Mesulam Center. All individuals recruited by the research Core at the center are well characterized tests standardized across all NIH funded Alzheimer Centers across the nation. Individuals with mild to moderate neurocognitive disorder due to AD will have an MMSE greater than >15 and Clinical Dementia Rating (CDR) between 0.5 and 2.. They will also have a history of neurocognitive-related agitation/anxiety, and a Beck Anxiety Index (BAI) or Rating for Anxiety in Dementia (RAID) greater than 8, suggestive of at least a mild level of anxiety.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • Mesulam Center for Cognitive Neurology and Alzheimer's Disease

    Chicago, Illinois, 60611

Other trials in United States

About this study

Official title: Neural Mechanisms of Induced Calmness After Listening to Improvisatory Music: An Investigation for Healthy Individuals and Persons With Alzheimer's Dementia

Clinically Designed Improvisatory Music (CDIM) is a form of improvised music based on calm-inducing sound parameters which brought relief to our cohort of neurology patients. As a direct sound-based approach, CDIM does not rely on autobiographical memory and may have wider applicability and generalizability. We wish to examine if CDIM decreases anxiety in 15 cognitively healthy individuals and 15 Alzheimer Disease patients with anxiety (AD-A).

Read the detailed description

The goal of this study is to identify the neural mechanisms of induced calmness through live clinically designed improvisatory music (CDIM) in cognitively healthy individuals and persons with Alzheimer's dementia suffering from agitation. This study is novel as most music interventions for dementia use familiar music and the underlying neural mechanism of calmness induced by music is not well known. We plan to investigate changes in 3 major large-scale brain networks using functional magnetic resonance imaging (fMRI). The major questions we plan to answer are as follows: 1. How does improvisatory music change the connectivity within brain emotion related networks in neurotypical individuals? 2. Does improvisatory music induce a state of calmness in individuals with Alzheimer's dementia and how? Based on objective evidence provided by this study we can justify further usage of music for patients with Alzheimer's, in particular, in the form of improvisation.

Being tested
Clinically Designed Improvisatory Music
Keywords
Anxiety, Alzheimer, Dementia, Agitation, Irritability, Music Intervention, Music Medicine, Music Improvisation
Medical subject headings
Alzheimer Disease, Anxiety Disorders, Dementia, Psychomotor Agitation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Clinically Designed Improvisatory MusicBehavioural

    Clinically Designed Improvisatory Music (CDIM) is a form of improvised music based on calm-inducing sound parameters which brought relief to our cohort of neurology patients.

Study groups in NCT05477862
Study groupRoleWhat they receive
Alzheimer Disease (AD)ExperimentalNot described
Receives: Behavioral: Clinically Designed Improvisatory Music
Cognitively Healthy (CH)ExperimentalNot described
Receives: Behavioral: Clinically Designed Improvisatory Music

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Neuropsychiatric Inventory (NPI) [NPI-1: pre-intervention; NPI-2: post-intervention]

    Change in NPI (NPI-2 minus NPI-1)

    Measured: Through study completion (3 years)

  2. Change in Beck Anxiety Inventory [BAI-1: pre-intervention; BAI-2: post-intervention]

    Change in BAI (BAI-2 minus BAI-1)

    Measured: Through study completion (3 years)

Secondary outcomes (5)

  1. Change in Systolic Blood Pressure [SBP-1: pre-intervention; SBP-2: post-intervention]

    Change in SBP (SBP-2 minus SBP-1)

    Measured: Through study completion (3 years)

  2. Change in Heart rate [HR-1: pre-intervention; HR-2: post-intervention]

    Change in HR (HR-2 minus HR-1)

    Measured: Through study completion (3 years)

  3. Change Respiratory Rate [RR-1: pre-intervention; RR-2: post-intervention]

    Change in RR (RR-2 minus RR-1)

    Measured: Through study completion (3 years)

  4. Change in Skin conductance [SC-1: pre-intervention; SC-2: post-intervention]

    Change in SC (SC-2 minus SC-1)

    Measured: Through study completion (3 years)

  5. Change in Resting state functional connectivity MRI

    Functional Connectivity within three resting state networks: Change in Default Network (DN), Change in Salience Network (SN), and Change in Reward Network (RN).

    Measured: Through study completion (3 years)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Jul 2022
  2. Study start1 Sep 2023
  3. Primary completion15 Dec 2026 (estimated)
  4. Study completion15 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
15 individuals with Alzheimer Disease (AD) and 15 cognitively healthy individuals.
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05477862
Sponsor's protocol ID
00215983
Status last verified
Aug 2026
First submitted
17 Jul 2022
Last updated
10 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Bonakdarpour B, McFadden A, Zlotkowski S, Huang D, Shaker M, Shibata B, Haben W, Brashear C, Sandoval A, Breitenbach C, Rodriguez C, Viamille J, Porter M, Galic K, Schaeve M, Thatcher D, Takarabe C. Neurology Telemusic Program at the Time of the COVID-19 Pandemic: Turning Hospital Time Into Aesthetic Time During Crisis. Front Neurol. 2021 Dec 13;12:749782. doi: 10.3389/fneur.2021.749782. eCollection 2021.

    PubMed 34966344

  • Lyketsos CG, Carrillo MC, Ryan JM, Khachaturian AS, Trzepacz P, Amatniek J, Cedarbaum J, Brashear R, Miller DS. Neuropsychiatric symptoms in Alzheimer's disease. Alzheimers Dement. 2011 Sep;7(5):532-9. doi: 10.1016/j.jalz.2011.05.2410.

    PubMed 21889116

  • Baird A, Samson S. Music and dementia. Prog Brain Res. 2015;217:207-35. doi: 10.1016/bs.pbr.2014.11.028. Epub 2015 Jan 31.

    PubMed 25725917

  • Assal F, Cummings JL. Neuropsychiatric symptoms in the dementias. Curr Opin Neurol. 2002 Aug;15(4):445-50. doi: 10.1097/00019052-200208000-00007.

    PubMed 12151841

  • Seeley WW, Menon V, Schatzberg AF, Keller J, Glover GH, Kenna H, Reiss AL, Greicius MD. Dissociable intrinsic connectivity networks for salience processing and executive control. J Neurosci. 2007 Feb 28;27(9):2349-56. doi: 10.1523/JNEUROSCI.5587-06.2007.

    PubMed 17329432

Questions about this trial

What is this clinical trial studying?

A study testing Clinically Designed Improvisatory Music in people with Alzheimer Disease, run by Northwestern University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Neuropsychiatric Inventory (NPI) [NPI-1: pre-intervention; NPI-2: post-intervention] (time frame: Through study completion (3 years)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05477862, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026.

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